A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol

NCT01618916 | Completed Phase 1 Results

• 2 other identifiers: 14354I5S-EW-EFJB
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will participate in the study for approximately 3 months not including screening. Screening is required within 42 days prior to the start of the study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)

  TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.

  Baseline through study completion (up to Day 127)

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014

  First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose

• PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])

  First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose

• PK: Time of Maximum Concentration (Tmax) of LY3015014

  First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose

• Percent Change From Baseline to Days 43, 57, and 127 in LDL-C

  Baseline, Day 43, Day 57, and Day 127

Study Arms (6)

1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks

EXPERIMENTAL

1.0 mg/kg LY3015014 given subcutaneously (SC) once every 2 weeks for 29 days.

Drug: LY3015014

1.0 mg/kg LY3015014 Every 4 Weeks

EXPERIMENTAL

1.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.

Drug: LY3015014

3.0 mg/kg LY3015014 Every 2 Weeks

EXPERIMENTAL

3.0 mg/kg LY3015014 given SC once every 2 weeks for 29 days.

Drug: LY3015014

3.0 mg/kg LY3015014 Every 4 Weeks

EXPERIMENTAL

3.0 mg/kg LY3015014 given SC once every 4 weeks for 29 days.

Drug: LY3015014

Placebo Every 2 Weeks

PLACEBO COMPARATOR

Saline injection (to match LY3015014) given SC once every 2 weeks for 29 days.

Other: Placebo

Placebo Every 4 Weeks

PLACEBO COMPARATOR

Saline injection (to match LY3015014) given SC once every 4 weeks for 29 days.

Other: Placebo

Interventions

LY3015014 DRUG

Administered SC

1.0 mg/kg LY3015014 Every 4 Weeks; 1.0 milligrams per kilogram (mg/kg) LY3015014 Every 2 Weeks; 3.0 mg/kg LY3015014 Every 2 Weeks; 3.0 mg/kg LY3015014 Every 4 Weeks

Placebo OTHER

Administered SC

Placebo Every 2 Weeks; Placebo Every 4 Weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be healthy males or females without childbearing potential as determined by medical history and physical examination, including first-generation Japanese participants
• Have body mass indexes of 18 to 35 kilograms per meter square (kg/m\^2), inclusive, at screening
• Have screening low-density lipoprotein cholesterol (LDL-C) of between 100 and 180 milligrams per deciliter (mg/dL), inclusive

You may not qualify if:

• Have known allergies to compounds related to LY3015014 or any components of the formulation or known clinically significant hypersensitivity to biologic agents
• Have a history of atopy, significant allergies to humanized monoclonal antibodies, clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions \[including but not limited to erythema multiforme major, linear immunoglobulin (Ig)A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study medication, or of interfering with the interpretation of data
• Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so during the study
• Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Honolulu, Hawaii, 96814, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

frovocimab

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 13, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 15, 2019
• Results First Posted: February 25, 2019

Record last verified: 2019-02

Locations

US (2)